Guidance for FDA Staff

Compliance Policy Guide

Sec. 100.250 Food Facility Registration –
Human and Animal Food

Draft Guidance
This guidance is being distributed for comment purposes only.

Although you can submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)), to
ensure that the agency considers your comments on this draft guidance before it begins work on
the final version of the guidance, submit either electronic or written comments on the draft
guidance within 30 days of publication in the Federal Register of the notice announcing the
availability of the draft guidance. Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be
identified with the docket number listed in the notice of availability that publishes in the Federal
Register.

For questions regarding this draft document contact the Center for Food Safety and Applied
Nutrition at 240-402-1887.

U.S. Department of Health and Human Services

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs
April 2013

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Table of Contents

I. Introduction

II. Background

III. Policy

IV. Regulatory Action Guidance

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Guidance for FDA Staff

Compliance Policy Guide
Sec. 100.250 Food Facility Registration –
Human and Animal Food

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s)
current thinking on this topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. You can use an alternative approach if the approach
satisfies the requirements of the applicable statutes and regulations. If you want to discuss an
alternative approach, contact the FDA staff responsible for implementing this guidance. If you
cannot identify the appropriate FDA staff, call the telephone number listed on the title page of
this guidance.

I. Introduction:
*The purpose of this document is to provide guidance for FDA staff on food facility registration
under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d),
including the requirement that certain food facilities register with FDA, the requirement that
registered facilities biennially renew their registrations with FDA, and FDA’s authority to
suspend a food facility’s registration.

FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.

II. Background:
Food Facility Registration

Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of
2002 (the Bioterrorism Act) (Pub. L. 107-188) amended the FD&C Act by adding section 415,
which established requirements for food facilities to register with FDA. Under section 415 of
the FD&C Act (21 U.S.C. 350d), owners, operators, or agents in charge of domestic and foreign

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facilities that manufacture, process, pack, or hold food for human or animal consumption in the
United States are required to register their facilities with FDA, unless an exception applies (see
21 CFR 1.226 and 1.227). The term “facility” is described in section 415(c)(1) of the FD&C Act
and defined by regulation in 21 CFR 1.227(b)(2). Facilities that do not have to register are listed
in 21 CFR 1.226. Certain other establishments are not required to register because they do not
manufacture, process, pack, or hold “food,” as defined in 21 CFR 1.227(b)(4). This definition
for “food” excludes food contact substances (including packaging materials), as defined in
section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)), and pesticides as defined in 7 U.S.C.
136(u). Thus, facilities that manufacture, process, pack, or hold only food contact substances or
only pesticides are not required to register with FDA under section 415 of the FD&C Act.

A domestic facility means any facility located in any State or Territory of the United States, the
District of Columbia, or the Commonwealth of Puerto Rico that manufactures, processes, packs,
or holds food for consumption in the United States (21 CFR 1.227(b)(2)(i)). A domestic food
facility that is required to register must register whether or not food from that facility enters
interstate commerce (21 CFR 1.225(b)). A foreign facility means a facility other than a domestic
facility that manufactures, processes, packs, or holds food for consumption in the United States
(21 CFR 1.227(b)(2)(ii)). Only facilities - domestic and foreign - that manufacture, process,
pack or hold food for consumption in the United States are required to register with FDA under
section 415 of the FD&C Act.

Under section 415(a)(2) of the FD&C Act, the registrant for a facility must notify FDA in a
timely manner of changes to the facility’s registration information. The failure to register a food
facility in accordance with section 415 is a prohibited act under section 301(dd) of the FD&C
Act (21 U.S.C. 331(dd)).

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4,
2011, amended section 415 of the FD&C Act in relevant part to require registrants for food
facilities to submit additional registration information to FDA, including the email address of the
contact person for a domestic facility, the email address of the U.S. agent for a foreign facility,
and an assurance that FDA will be permitted to inspect the facility at the times and in the manner
permitted by the FD&C Act. FSMA also amended section 415 of the FD&C Act to require food
facilities to renew registrations with FDA biennially, and to provide FDA with the authority to
suspend the registration of a food facility in certain circumstances, as discussed further below.
Further, FSMA amended section 801(l)(1) of the FD&C Act (21 U.S.C. 381(l)) to provide that if
an article of food being imported or offered for import into the United States is from a foreign
facility for which a registration has not been submitted to FDA, as required by section 415 of the
FD&C Act, or is from a foreign facility for which a registration has been suspended under
section 415, the article must be held at the port of entry for the article, and may not be delivered
to the importer, owner, or consignee of the article, until the foreign facility is registered. Unlike
the requirements related to a drug or device establishment, which provide that the failure of such
an establishment to register with FDA, as required under section 510 of the FD&C Act (21
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U.S.C. 360), causes the drugs or devices manufactured, prepared, propagated, compounded, or
processed in such an establishment to be misbranded under section 502(o) of the FD&C Act (21
U.S.C. 352 (o)), and therefore subject such misbranded drugs and devices to refusal of admission
under section 801(a) of the FD&C Act, the failure of a food facility to register with FDA, or the
suspension of a food facility’s registration, alone does not cause food manufactured, processed,
packed, or held in such facility to be misbranded under the FD&C Act.

FDA's guidance "What You Need to Know About Registration of Food Facilities" provides
information on how to submit registration for a food facility, including electronic registration, at
www.access.fda.gov.

Biennial Registration Renewal

Section 415(a)(3) of the FD&C act, as amended by FSMA, requires food facilities required to
register with FDA to renew such registrations biennially. Specifically, section 415(a)(3) requires
that, during the period beginning on October 1 and ending on December 31 of each even-
numbered year, a food facility that has submitted a registration to FDA must submit to FDA a
renewal registration that contains the required information specified in section 415(a)(2). A
registrant that has not had any changes to the previously submitted registration information may
use an abbreviated registration renewal process provided by FDA. A food facility that fails to
renew its registration with FDA, as required by section 415(a)(3), has failed to register in
accordance with section 415 and thereby has committed a prohibited act under section 301(dd)
of the FD&C Act. However, there was a delay in FDA’s implementation of biennial registration
renewal for the 2012 cycle, and registration renewal did not become available until October 22,
2012. FDA has provided guidance on its plans regarding the delay in the implementation of
biennial registration renewal for the 2012 cycle in another food facility registration guidance
entitled Guidance for Industry: Questions and Answers Regarding Food Facility Registration
(Fifth Edition), available at
www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefen
se/ucm331959.htm.

Suspension of Registration

Section 415(b) of the FD&C Act, as amended by FSMA, provides that FDA may suspend the
registration of a food facility in certain circumstances. Specifically, if FDA determines that food
manufactured, processed, packed, received, or held by a registered facility has a reasonable
probability of causing serious adverse health consequences or death to humans or animals, FDA
may by order suspend the registration of a facility that:
1. Created, caused, or was otherwise responsible for such reasonable probability; or
2. Knew of, or had reason to know of, such reasonable probability; and packed, received, or
held such food.

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Under section 415(b)(4) of the FD&C Act, as amended by FSMA, if the registration of a human
or animal food facility is suspended, no person can import or export, or offer to import or export,
food from the facility into the United States, or otherwise introduce food from the facility into
interstate or intrastate commerce in the United States while the suspension order for the facility
is in effect. Under section 301(d) of the FD&C Act (21 U.S.C. 331(d)), the introduction or
delivery for introduction into interstate commerce of an article of food in violation of section 415
is a prohibited act. Section 801(l) of the FD&C Act, as amended by FSMA, provides, in relevant
part, that an article of food being imported or offered for import into the United States that is
from a foreign facility for which a registration has been suspended under section 415 must be
held at the port of entry for the article of food, and may not be delivered to the importer, owner,
or consignee of the article.

III. Policy:
Food Facility Registration

FDA will enforce the registration requirements of section 415 of the FD&C Act and
implementing regulations in 21 CFR Part 1, Subpart H as appropriate in each situation. The
failure to register a food facility in accordance with section 415 is a prohibited act under section
301(dd) of the FD&C Act. FDA may consider a facility to not be registered in accordance with
section 415 if: (1) the facility has not submitted a registration to FDA; (2) the facility’s
registration is incomplete; or (3) the facility’s registration has expired because the facility failed
to renew is registration.

FDA’s prior notice for imported foods system is the agency’s primary tool for ensuring that
foreign facilities that offer food for import into the United States are registered under section 415
of the FD&C Act. (See 21 CFR 1.285 and CPG Sec. 110.310 Prior Notice of Imported Food
Under the Public Health Security and Bioterrorism Preparedness Response Act of 2002). If FDA
determines that a foreign food facility is not registered in accordance with section 415 and 21
CFR Part 1, Subpart H, FDA will hold the food being imported or offered for import into the
United States from the foreign facility at the port of entry (as defined in 19 CFR 101.1), in
accordance with section 801(l) of the FD&C Act, unless U.S. Customs Border Protection (CBP)
concurrence is obtained for the export of the food and the food is immediately exported from the
port of arrival (as defined in 21 CFR 1.276(b)(11) (see 21 CFR 1.285(b)). FDA will not permit
the food to be delivered to the importer, owner, or consignee until the foreign facility is
registered in accordance with section 415 and 21 CFR Part 1, Subpart H, and the appropriate
registration number is provided in prior notice as specified in 21 CFR 1.285(i). FDA may allow
the food held at the port of entry to be moved to a secure facility, as appropriate (21 CFR
1.285(c)(2)). However, FDA ordinarily will not allow the food to be transferred by any person
from the port of entry into the U.S. or from the secure facility.

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Biennial Registration Renewal

FDA will consider a registration for a food facility to be expired if the registration is not
renewed, as required by section 415(a)(3) of the FD&C Act. Thus, if a food facility that
previously submitted a registration to FDA does not submit a registration renewal to FDA during
the period beginning on October 1 and ending on December 31 of each even-numbered year,
FDA will consider the registration for the facility to be expired, and will notify the registrant for
the facility that the facility’s registration has expired. FDA will consider a food facility with an
expired registration to have failed to register in accordance with section 415. As previously
stated in this document, the failure of a food facility to renew its registration with FDA, as
required by section 415(a)(3), means that the facility has failed to register in accordance with
section 415 of the FD&C Act. The failure to register a food facility in accordance with section
415 is a prohibited act under section 301(dd) of the FD&C Act.

Suspension of Registration

Under section 415(b)(4) of the FD&C Act, if the registration of a food facility is suspended, no
person can import or export, or offer to import or export, food from the facility into the United
States, or otherwise introduce food from the facility into interstate or intrastate commerce in the
United States while the suspension order for the facility is in effect. The introduction or delivery
for introduction into interstate commerce of an article of food in violation of section 415 is a
prohibited act under section 301(d) of the FD&C Act.

If a domestic facility that is subject to a registration suspension order introduces food from such
facility into intrastate or interstate commerce, FDA may pursue enforcement action, such as
administrative detention, seizure, injunction, mandatory recall, prosecution, or a combination of
such actions, as appropriate, provided that the applicable legal requirements are satisfied.

If FDA determines that a food being imported or offered for import into the United States is from
a foreign food facility with a suspended registration, FDA will hold the food at the port of entry
according to section 801(l) of the FD&C Act.

IV. Regulatory Action Guidance:

Food Facility Registration

The owner, operator, or agent in charge of a domestic facility, as defined in 21 CFR

1.227(b)(2)(i), must register the facility with FDA, unless exempted, as provided in 21 CFR
1.226, whether or not food from the facility enters interstate commerce. FDA anticipates that it,
or a State agency acting on behalf of FDA, may discover a domestic facility's failure to be
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registered during a routine inspection of the facility. During an inspection, the investigator
should determine whether a facility is registered and whether information in the registration is
accurate and current. If the investigator identifies a registration violation, the investigator should
advise the facility’s management of the requirement to register or the requirement to update
mandatory elements of the registration. The investigator should also provide the management
with FDA’s guidance, “What You Need to Know About Registration of Food Facilities.” The
investigator should document in the establishment inspection report the information obtained
regarding the facility’s registration. The investigator also should document information provided
to the management of the unregistered facility regarding the registration requirements of section
415 of the FD&C Act.

The Districts have direct reference authority to issue an Untitled Letter to a domestic food
facility and the Centers (CFSAN or CVM, as appropriate) may issue an Untitled Letter to a
foreign food facility when the facility is required to register under section 415 of the FD&C Act,
the facility has not registered, and the following conditions apply:
 The facility manufactures, processes, packs, or holds food for human or animal
consumption in the U.S. and it is clear that the facility is not exempt from the registration
requirement;
 The establishment file documents that management at the facility have been advised
orally or in writing of the duty of the owner, operator, or agent in charge to register the
facility; and
 The authoring office has verified that the facility is not registered.

CFSAN or CVM, as appropriate, should advise the Division of Food Defense Targeting (DFDT),
formerly known as the Prior Notice Center, when a foreign facility has not registered with FDA
in accordance with section 415. The DFDT should add applicable prior notice targeting criteria
into OASIS/MARCS to identify food articles offered for import into the U.S. from a foreign
facility that is not registered with FDA in accordance with section 415. Articles of food from the
foreign facility for which a registration has not been submitted to FDA in accordance with
section 415 should be held at the port of entry pursuant to section 801(l) of the FD&C Act.

Biennial Registration Renewal

CFSAN, Office of Compliance, or CVM, Office Of Surveillance and Compliance, as

appropriate, may notify a facility that has not submitted a registration renewal to FDA, as
required by section 415(a)(3) of the FD&C Act, of the requirement for biennial registration
renewal.

Suspension of Registration

The District or appropriate Center may recommend suspension of registration for a human or
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animal food facility based on evidence that food manufactured, processed, packed, received, or
held by the facility has a reasonable probability of causing serious adverse health consequences
or death to humans or animals and the facility:
1. Created, caused, or was otherwise responsible for such reasonable probability; or
2. Knew of, or had reason to know of, such reasonable probability; and packed, received, or
held such food. (See section 415(b) of the FD&C Act).

Suspension of a food facility’s registration may be considered whenever the criteria for
suspension in section 415(b) of the FD&C Act are met. Examples of circumstances in which the
District or Center should give priority consideration to recommending suspension of a food
facility’s registration include, but are not limited to, the following:
1. Inspectional or other evidence (e.g., evidence of Class 1 recall situation or evidence of
food associated with foodborne illnesses) indicates that the firm has significant violations
of the FD&C Act and has not permanently corrected the source of the problem.
2. The firm is subject to a prehearing order to cease distribution and give notice under
FDA’s mandatory recall authority, section 423(b) of the FD&C Act (21 U.S.C. 350l(b)).
3. The firm is subject to an emergency permit order under 21 CFR Part 108 or an
emergency permit recommendation is being considered.
4. The firm is a foreign facility and food from the firm is subject to an Import Alert that
provides for detention without physical examination because the food may cause serious
adverse health consequences or death to humans or animals.

Under section 415(b)(4) of the FD&C Act, if the registration of a food facility is suspended, no
person can import or export, or offer to import or export, food from the facility into the United
States, or otherwise introduce food from the facility into interstate or intrastate commerce in the
United States while the suspension order for the facility is in effect. The introduction or delivery
for introduction into interstate commerce of any article of food in violation of section 415 is a
prohibited act under section 301(d) of the FD&C Act. While a registration suspension order is in
effect for a domestic facility, the District in which the facility is located should take appropriate
actions to ensure that food from the facility is not introduced into interstate or intrastate
commerce in the United States.

CFSAN or CVM, as appropriate, should advise the DFDT when a registration suspension order
is issued to a foreign facility. The DFDT should add applicable prior notice targeting criteria
into OASIS/MARCS to identify food articles offered for import into the U.S. from the foreign
facility. While the registration suspension order is in effect, FDA can hold articles of food from
the foreign facility at the port of entry pursuant to section 801(l) of the FD&C Act.*

*Material between asterisks is new or revised*

Issued: 12/2003
Revised: 11/2004, 8/2006, [insert date]
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